Regulatory Affairs

In our “Regulatory Affairs” section you can access regulatory resources within Oregon, as well as nationwide. If you have a question about our regulatory resources or are aware of a resource that we should include, please submit it through the following: Feedback.

Regulatory Resources

• FDA
• CDRH
• CBER
• Electronic Records/Signatures
• Division of Small Manufacturers
• GMP/Quality Systems
• Medwatch
• IRB Guidance
• Exporting Medical Devices
• Freedom of Information
• Code of Federal Regulations
• Federal Register Online
• Food, Drug, and Cosmetic Act
• Regulations.gov
• Pacific Regional Chapter of the Society of Quality Assurance
• Regulatory Affairs Professional Society (RAPS)
• American National Standards Institute
• International Organization for Standardization
• Medical Devices Agency, UK
• British Association of Research Quality Assurance
• EudraNet

Related Resources:

• Facilities
• Health & Safety
• Oregon BioHistory

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